PALACOS MV bone cement recalled because ampoules may not break
Heraeus Medical is recalling PALACOS MV pro 40 and PALACOS MV pro 80 bone cement because an unfortunate combination of factors can leave ampoules unbroken, so no appropriate cement dough is formed.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Scored 2 because the record's stated consequence is that the product cannot be used, with no patient harm or reported injury.
Plain-English summary
PALACOS MV pro 40 and PALACOS MV pro 80, catalog numbers 5150633 and 5150635, is being recalled by Heraeus Medical GmbH. The record describes the product as radiopaque poly(methyl methacrylate)-based bone cement, pre-filled into a mixing device.
The record cites an increase of complaints regarding the breakage of the ampoules within the device systems. An extensive investigation revealed that multiple factors have an impact on ampoule breakage, and an unfortunate combination of these influence factors can lead to unbreakable ampoules. If none or not all ampoules break, the product cannot be used on the patient since no appropriate cement dough is formed.
The record does not state a quantity. Affected product carries UDI-DIs 04260102135338 and 04260102135369. Distribution was international, to countries including Australia, Belgium, Denmark, Finland and Germany. The FDA has classified the action as Class II.
The stated consequence in the enforcement record is that the product cannot be used, and no injuries are reported. Facilities should follow Heraeus Medical's instructions.
The recalled product
- Product
- Medline medical procedure convenience kits labeled as: 1) WCH BARI-GASTRECTOMY CDS, REF CDS860237AF; 2) ROBOTIC PROCEDURE, REF CDS982128Q; 3) CUH THORACIC, REF CDS984338M; 4) THORACIC PROCEDURE, REF CDS984640I; 5) DAVINCI ROBOTIC PACK-LF, REF DYNJ0525321O; 6) LAP CHO
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Bone cement
- Affected units
- 4,536
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- REF CDS860237AF: UDI/DI 10198459232626 (EA) 40198459232627 (CS)
- Lot Number 25FBK870
- Lot Number 25EBD110
- REF CDS982128Q: UDI/DI 10198459008245 (EA) 40198459008246 (CS)
- Lot Number 25EBC253
- Lot Number 25DBG393
- REF CDS984338M: UDI/DI 10198459148101 (EA) 40198459148102 (CS)
- Lot Number 25FBQ303
- Lot Number 25EBD631
- Lot Number 25DBM322
- REF CDS984640I: UDI/DI 10198459318955 (EA) 40198459318956 (CS)
- Lot Number 25DBT807
- REF DYNJ0525321O: UDI/DI 10198459236907 (EA) 40198459236908 (CS)
- Lot Number 25DMG099
- Lot Number 25CMJ006
- REF DYNJ57640F: UDI/DI 10198459011115 (EA) 40198459011116 (CS)
- Lot Number 25FDB347
- REF DYNJ62594D: UDI/DI 10198459049767 (EA) 40198459049768 (CS)
- Lot Number 25EBK539
- Lot Number 25DBD145
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 6 recalled by Medline Industries, LP under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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